Respironics (Ireland) Limited
IrelandFDA applicant, unverified
- Devices
- 1
What Respironics (Ireland) Limited makes
Respironics (Ireland) Limited manufactures non-invasive ventilatory support devices, including the BIPAP FOCUS system designed for respiratory therapy. This equipment is intended for patients requiring positive airway pressure therapy, such as those with sleep apnea or chronic respiratory conditions.
The company’s portfolio is regulated under Class II medical devices in the US, with relevant products authorised via the FDA’s 510(k) clearance process. The manufacturer is based in the United States.
Catalogue
Bipap Focus Ref K053168
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Respironics (Ireland) Limited have in the registry?
The registry currently lists 1 device for Respironics (Ireland) Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Respironics (Ireland) Limited's devices?
Among its 1 most recently registered device, Respironics (Ireland) Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Respironics (Ireland) Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Respironics (Ireland) Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Respironics (Ireland) Limited in the registry?
The most recently registered devices listed for Respironics (Ireland) Limited include BIPAP FOCUS.